# K081927: Renu Medical Oximetry Sensor, Adult, Ped, Inf,Neo

- Pathway: 510(k) (Traditional)
- Applicant: Renu Medical, Inc.
- Decided: Feb 6, 2009 after 214 days
- Product code: NLF (Oximeter, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Masimo LNCS Adtx Oximetry sensor: named in the summary without a submission number
- (no number) Masimo LNCS Pdtx Oximetry sensor: named in the summary without a submission number
- (no number) Masimo LNCS Inf Oximetry sensor: named in the summary without a submission number
- (no number) Masimo LNCS Neo Oximetry sensor: named in the summary without a submission number

## Most influential descendants
- K111773: Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and Neonate (2011), 0 descendants of its own

## Indications for use
The ReNu Medical Reprocessed Oximetry Sensors are intended as single patient use 02 transducer/accessory sensors for use in conjunction with the Masimo TMMOximeter system. The LNCS Adult is used for patients >30 kg. The LNCS Pediatric is used for patients 10-50 kg. The LNCS Infant is used for patients 3-20 kg. The LNCS Neo is used for neonates <3 kg or adults >40 kg. All sensors are used for non-invasive monitoring of pulse oxygen hemoglobin saturation (Sp02) and pulse rate.

Source page: https://510kreport.com/device/K081927
Methodology: https://510kreport.com/methodology